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Walking 7,000 steps per day may be enough to reduce mortality risk
based on prospective data from more than 2,000 people.
Findings were consistent regardless of race or sex, and step intensity had no impact on mortality risk, reported lead author Amanda E. Paluch, PhD, of the University of Massachusetts Amherst, and colleagues.
“In response to the need for empirical data on the associations of step volume and intensity with mortality in younger and diverse populations, we conducted a prospective study in middle-aged Black and White adults followed up for mortality for approximately 11 years,” the investigators wrote in JAMA Network Open. “The objectives of our study were to examine the associations of step volume and intensity with mortality overall and by race and sex.”
Steps per day is easy to communicate
Dr. Paluch noted that steps per day is a “very appealing metric to quantify activity,” for both researchers and laypeople.
“Steps per day is simple and easy to communicate in public health and clinical settings,” Dr. Paluch said in an interview. “Additionally, the dramatic growth of wearable devices measuring steps makes it appealing and broadens the reach of promoting physical activity to many individuals. Walking is an activity that most of the general population can pursue. It can also be accumulated throughout daily living and may seem more achievable to fit into busy lives than a structured exercise session.”
The present investigation was conducted as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study. The dataset included 2,110 participants ranging from 38-50 years of age, with a mean age of 45.2 years. A slightly higher proportion of the subjects were women (57.1%) and White (57.9%).
All participants wore an ActiGraph 7164 accelerometer for 1 week and were then followed for death of any cause, with a mean follow-up of 10.8 years. Multivariable-adjusted Cox proportional hazards models included a range of covariates, such as smoking history, body weight, alcohol intake, blood pressure, total cholesterol, and others. Step counts were grouped into low (less than 7,000 steps per day), moderate (7,000-9,999), and high (at least 10,000 steps per day) categories.
Compared with individuals who took less than 7,000 steps per day, those who took 7,000-9,000 steps per day had a 72% reduced risk of mortality (hazard ratio, 0.28; 95% confidence interval, 0.15-0.54). Going beyond 10,000 steps appeared to add no benefit, based on a 55% lower risk of all-cause mortality in the highly active group, compared with those taking less than 7,000 steps per day (HR, 0.45; 95% CI, 0.25-0.81).
Walking faster didn’t appear to help either, as stepping intensity was not associated with mortality risk; however, Dr. Paluch urged a cautious interpretation of this finding, calling it “inconclusive,” and suggesting that more research is needed.
“It is also important to note that this study only looked at premature all-cause mortality, and therefore the results may be different for other health outcomes, such as the risk of cardiovascular disease, or diabetes, cancer, or mental health outcomes,” Dr. Paluch said.
“The results from our study demonstrated that those who are least active have the most to gain,” Dr. Paluch said. “Even small incremental increases in steps per day are associated with a lower mortality risk during middle age. A walking plan that gradually works up toward 7,000-10,000 steps per day in middle-aged adults may have health benefits and lower the risk of premature mortality.”
Causality cannot be confirmed
According to Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), the study size, diverse population, and length of follow-up should increase confidence in the findings, although a causal relationship remains elusive.
“As this study is observational, causality between step count and mortality cannot be confirmed; however, the authors accounted for many factors, and the association was consistent in different analyses and with prior literature,” Dr. Joundi said in an interview. “The authors did not assess the risk of other important events like stroke and heart attack, and these could be addressed in a future study.”
Dr. Joundi, who recently published a study linking exercise with a 50% reduction in mortality after stroke, noted that “physical activity has innumerable benefits, and it’s important that people engage in activity that can be regular and consistent, regardless of the type or intensity.”
To this end, he highlighted the use of “devices capable of monitoring step count, which can be an important motivational tool,” and suggested that these findings may bring a sigh of relief to step counters who come up a little short on a common daily goal.
“A target of 10,000 steps is often used for public health promotion, and this study now provides convincing observational evidence that it may be an optimal step count target for mortality reduction,” Dr. Joundi said. “However, if 10,000 steps per day is not feasible, 7,000 steps seems to be a very reasonable target given its association with markedly lower mortality in this study.”
Not all step counters are equal
Unfortunately, such recommendations are complicated by uncertainty in measurement, as widely used step counting devices, like smart watches, may not yield the same results as research-grade accelerometers, according to Nicole L. Spartano, PhD, of Boston University.
“Many comparison studies have been conducted in laboratory settings among young healthy adults, but these do not necessarily reflect real-life wear experiences that will be generalizable to the population as a whole,” Dr. Spartano wrote in an accompanying editorial.
She called for large-scale comparison studies to compare research-grade and consumer devices.
“The reason for conducting comparison studies is not to develop distinct guidelines for different devices or subgroups of the population, but rather to understand the variability so that we can develop one clear message that is most appropriate to the public,” Dr. Spartano wrote. “Some devices may have bias in terms of step measurement at different activity intensity and may not record steps as accurately in older adults or individuals with obesity or mobility disorders. For example, when adults who were obese wore an ActiGraph monitor in a laboratory setting, the device only recorded 80% of steps walked at a moderate pace, while other devices recorded close to 100% of steps walked. If we in the public health community are to move toward using these devices more for physical activity prescription, these details will need to be explored in more depth.”
CARDIA was conducted and supported by the National Heart, Lung, and Blood Institute in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Some study authors received grants from the National Institutes of Health and the Kaiser Foundation Research Institute. Dr Spartano disclosed relationships with Novo Nordisk, the American Heart Association, the Alzheimer’s Association, and the National Institutes of Health. Dr. Joundi and Dr. Paluch disclosed no relevant financial relationships.
based on prospective data from more than 2,000 people.
Findings were consistent regardless of race or sex, and step intensity had no impact on mortality risk, reported lead author Amanda E. Paluch, PhD, of the University of Massachusetts Amherst, and colleagues.
“In response to the need for empirical data on the associations of step volume and intensity with mortality in younger and diverse populations, we conducted a prospective study in middle-aged Black and White adults followed up for mortality for approximately 11 years,” the investigators wrote in JAMA Network Open. “The objectives of our study were to examine the associations of step volume and intensity with mortality overall and by race and sex.”
Steps per day is easy to communicate
Dr. Paluch noted that steps per day is a “very appealing metric to quantify activity,” for both researchers and laypeople.
“Steps per day is simple and easy to communicate in public health and clinical settings,” Dr. Paluch said in an interview. “Additionally, the dramatic growth of wearable devices measuring steps makes it appealing and broadens the reach of promoting physical activity to many individuals. Walking is an activity that most of the general population can pursue. It can also be accumulated throughout daily living and may seem more achievable to fit into busy lives than a structured exercise session.”
The present investigation was conducted as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study. The dataset included 2,110 participants ranging from 38-50 years of age, with a mean age of 45.2 years. A slightly higher proportion of the subjects were women (57.1%) and White (57.9%).
All participants wore an ActiGraph 7164 accelerometer for 1 week and were then followed for death of any cause, with a mean follow-up of 10.8 years. Multivariable-adjusted Cox proportional hazards models included a range of covariates, such as smoking history, body weight, alcohol intake, blood pressure, total cholesterol, and others. Step counts were grouped into low (less than 7,000 steps per day), moderate (7,000-9,999), and high (at least 10,000 steps per day) categories.
Compared with individuals who took less than 7,000 steps per day, those who took 7,000-9,000 steps per day had a 72% reduced risk of mortality (hazard ratio, 0.28; 95% confidence interval, 0.15-0.54). Going beyond 10,000 steps appeared to add no benefit, based on a 55% lower risk of all-cause mortality in the highly active group, compared with those taking less than 7,000 steps per day (HR, 0.45; 95% CI, 0.25-0.81).
Walking faster didn’t appear to help either, as stepping intensity was not associated with mortality risk; however, Dr. Paluch urged a cautious interpretation of this finding, calling it “inconclusive,” and suggesting that more research is needed.
“It is also important to note that this study only looked at premature all-cause mortality, and therefore the results may be different for other health outcomes, such as the risk of cardiovascular disease, or diabetes, cancer, or mental health outcomes,” Dr. Paluch said.
“The results from our study demonstrated that those who are least active have the most to gain,” Dr. Paluch said. “Even small incremental increases in steps per day are associated with a lower mortality risk during middle age. A walking plan that gradually works up toward 7,000-10,000 steps per day in middle-aged adults may have health benefits and lower the risk of premature mortality.”
Causality cannot be confirmed
According to Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), the study size, diverse population, and length of follow-up should increase confidence in the findings, although a causal relationship remains elusive.
“As this study is observational, causality between step count and mortality cannot be confirmed; however, the authors accounted for many factors, and the association was consistent in different analyses and with prior literature,” Dr. Joundi said in an interview. “The authors did not assess the risk of other important events like stroke and heart attack, and these could be addressed in a future study.”
Dr. Joundi, who recently published a study linking exercise with a 50% reduction in mortality after stroke, noted that “physical activity has innumerable benefits, and it’s important that people engage in activity that can be regular and consistent, regardless of the type or intensity.”
To this end, he highlighted the use of “devices capable of monitoring step count, which can be an important motivational tool,” and suggested that these findings may bring a sigh of relief to step counters who come up a little short on a common daily goal.
“A target of 10,000 steps is often used for public health promotion, and this study now provides convincing observational evidence that it may be an optimal step count target for mortality reduction,” Dr. Joundi said. “However, if 10,000 steps per day is not feasible, 7,000 steps seems to be a very reasonable target given its association with markedly lower mortality in this study.”
Not all step counters are equal
Unfortunately, such recommendations are complicated by uncertainty in measurement, as widely used step counting devices, like smart watches, may not yield the same results as research-grade accelerometers, according to Nicole L. Spartano, PhD, of Boston University.
“Many comparison studies have been conducted in laboratory settings among young healthy adults, but these do not necessarily reflect real-life wear experiences that will be generalizable to the population as a whole,” Dr. Spartano wrote in an accompanying editorial.
She called for large-scale comparison studies to compare research-grade and consumer devices.
“The reason for conducting comparison studies is not to develop distinct guidelines for different devices or subgroups of the population, but rather to understand the variability so that we can develop one clear message that is most appropriate to the public,” Dr. Spartano wrote. “Some devices may have bias in terms of step measurement at different activity intensity and may not record steps as accurately in older adults or individuals with obesity or mobility disorders. For example, when adults who were obese wore an ActiGraph monitor in a laboratory setting, the device only recorded 80% of steps walked at a moderate pace, while other devices recorded close to 100% of steps walked. If we in the public health community are to move toward using these devices more for physical activity prescription, these details will need to be explored in more depth.”
CARDIA was conducted and supported by the National Heart, Lung, and Blood Institute in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Some study authors received grants from the National Institutes of Health and the Kaiser Foundation Research Institute. Dr Spartano disclosed relationships with Novo Nordisk, the American Heart Association, the Alzheimer’s Association, and the National Institutes of Health. Dr. Joundi and Dr. Paluch disclosed no relevant financial relationships.
based on prospective data from more than 2,000 people.
Findings were consistent regardless of race or sex, and step intensity had no impact on mortality risk, reported lead author Amanda E. Paluch, PhD, of the University of Massachusetts Amherst, and colleagues.
“In response to the need for empirical data on the associations of step volume and intensity with mortality in younger and diverse populations, we conducted a prospective study in middle-aged Black and White adults followed up for mortality for approximately 11 years,” the investigators wrote in JAMA Network Open. “The objectives of our study were to examine the associations of step volume and intensity with mortality overall and by race and sex.”
Steps per day is easy to communicate
Dr. Paluch noted that steps per day is a “very appealing metric to quantify activity,” for both researchers and laypeople.
“Steps per day is simple and easy to communicate in public health and clinical settings,” Dr. Paluch said in an interview. “Additionally, the dramatic growth of wearable devices measuring steps makes it appealing and broadens the reach of promoting physical activity to many individuals. Walking is an activity that most of the general population can pursue. It can also be accumulated throughout daily living and may seem more achievable to fit into busy lives than a structured exercise session.”
The present investigation was conducted as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study. The dataset included 2,110 participants ranging from 38-50 years of age, with a mean age of 45.2 years. A slightly higher proportion of the subjects were women (57.1%) and White (57.9%).
All participants wore an ActiGraph 7164 accelerometer for 1 week and were then followed for death of any cause, with a mean follow-up of 10.8 years. Multivariable-adjusted Cox proportional hazards models included a range of covariates, such as smoking history, body weight, alcohol intake, blood pressure, total cholesterol, and others. Step counts were grouped into low (less than 7,000 steps per day), moderate (7,000-9,999), and high (at least 10,000 steps per day) categories.
Compared with individuals who took less than 7,000 steps per day, those who took 7,000-9,000 steps per day had a 72% reduced risk of mortality (hazard ratio, 0.28; 95% confidence interval, 0.15-0.54). Going beyond 10,000 steps appeared to add no benefit, based on a 55% lower risk of all-cause mortality in the highly active group, compared with those taking less than 7,000 steps per day (HR, 0.45; 95% CI, 0.25-0.81).
Walking faster didn’t appear to help either, as stepping intensity was not associated with mortality risk; however, Dr. Paluch urged a cautious interpretation of this finding, calling it “inconclusive,” and suggesting that more research is needed.
“It is also important to note that this study only looked at premature all-cause mortality, and therefore the results may be different for other health outcomes, such as the risk of cardiovascular disease, or diabetes, cancer, or mental health outcomes,” Dr. Paluch said.
“The results from our study demonstrated that those who are least active have the most to gain,” Dr. Paluch said. “Even small incremental increases in steps per day are associated with a lower mortality risk during middle age. A walking plan that gradually works up toward 7,000-10,000 steps per day in middle-aged adults may have health benefits and lower the risk of premature mortality.”
Causality cannot be confirmed
According to Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), the study size, diverse population, and length of follow-up should increase confidence in the findings, although a causal relationship remains elusive.
“As this study is observational, causality between step count and mortality cannot be confirmed; however, the authors accounted for many factors, and the association was consistent in different analyses and with prior literature,” Dr. Joundi said in an interview. “The authors did not assess the risk of other important events like stroke and heart attack, and these could be addressed in a future study.”
Dr. Joundi, who recently published a study linking exercise with a 50% reduction in mortality after stroke, noted that “physical activity has innumerable benefits, and it’s important that people engage in activity that can be regular and consistent, regardless of the type or intensity.”
To this end, he highlighted the use of “devices capable of monitoring step count, which can be an important motivational tool,” and suggested that these findings may bring a sigh of relief to step counters who come up a little short on a common daily goal.
“A target of 10,000 steps is often used for public health promotion, and this study now provides convincing observational evidence that it may be an optimal step count target for mortality reduction,” Dr. Joundi said. “However, if 10,000 steps per day is not feasible, 7,000 steps seems to be a very reasonable target given its association with markedly lower mortality in this study.”
Not all step counters are equal
Unfortunately, such recommendations are complicated by uncertainty in measurement, as widely used step counting devices, like smart watches, may not yield the same results as research-grade accelerometers, according to Nicole L. Spartano, PhD, of Boston University.
“Many comparison studies have been conducted in laboratory settings among young healthy adults, but these do not necessarily reflect real-life wear experiences that will be generalizable to the population as a whole,” Dr. Spartano wrote in an accompanying editorial.
She called for large-scale comparison studies to compare research-grade and consumer devices.
“The reason for conducting comparison studies is not to develop distinct guidelines for different devices or subgroups of the population, but rather to understand the variability so that we can develop one clear message that is most appropriate to the public,” Dr. Spartano wrote. “Some devices may have bias in terms of step measurement at different activity intensity and may not record steps as accurately in older adults or individuals with obesity or mobility disorders. For example, when adults who were obese wore an ActiGraph monitor in a laboratory setting, the device only recorded 80% of steps walked at a moderate pace, while other devices recorded close to 100% of steps walked. If we in the public health community are to move toward using these devices more for physical activity prescription, these details will need to be explored in more depth.”
CARDIA was conducted and supported by the National Heart, Lung, and Blood Institute in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Some study authors received grants from the National Institutes of Health and the Kaiser Foundation Research Institute. Dr Spartano disclosed relationships with Novo Nordisk, the American Heart Association, the Alzheimer’s Association, and the National Institutes of Health. Dr. Joundi and Dr. Paluch disclosed no relevant financial relationships.
FROM JAMA NETWORK OPEN
Open notes: Legal issues
In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”
This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).1 The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.
Thus far, few patients have been informed about the new regulation.2 By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.
The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.
With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.
There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.3 Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”4 While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.
The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.3
In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.5 One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”3
In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).6 The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.
Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,4 this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.5
Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.5 Patients report that they understand and value the information provided to them in their medical records,7 and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.8
Importantly, open notes can increase patient engagement and patients’ trust in their physicians,9 thereby improving the doctor-patient relationship.3 And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.3 Additionally, it is predicted that open notes may, in fact, decrease legal liability.9 By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.10
The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.5 Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.
Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.
This article was updated Sept. 9, 2021.
References
1. Fed Regist. 2020 May;85(85):25642-961.
2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.
3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.
4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.
5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.
6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access
7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.
8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.
9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.
10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.
In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”
This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).1 The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.
Thus far, few patients have been informed about the new regulation.2 By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.
The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.
With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.
There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.3 Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”4 While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.
The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.3
In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.5 One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”3
In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).6 The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.
Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,4 this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.5
Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.5 Patients report that they understand and value the information provided to them in their medical records,7 and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.8
Importantly, open notes can increase patient engagement and patients’ trust in their physicians,9 thereby improving the doctor-patient relationship.3 And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.3 Additionally, it is predicted that open notes may, in fact, decrease legal liability.9 By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.10
The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.5 Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.
Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.
This article was updated Sept. 9, 2021.
References
1. Fed Regist. 2020 May;85(85):25642-961.
2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.
3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.
4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.
5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.
6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access
7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.
8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.
9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.
10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.
In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”
This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).1 The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.
Thus far, few patients have been informed about the new regulation.2 By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.
The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.
With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.
There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.3 Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”4 While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.
The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.3
In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.5 One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”3
In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).6 The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.
Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,4 this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.5
Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.5 Patients report that they understand and value the information provided to them in their medical records,7 and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.8
Importantly, open notes can increase patient engagement and patients’ trust in their physicians,9 thereby improving the doctor-patient relationship.3 And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.3 Additionally, it is predicted that open notes may, in fact, decrease legal liability.9 By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.10
The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.5 Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.
Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.
This article was updated Sept. 9, 2021.
References
1. Fed Regist. 2020 May;85(85):25642-961.
2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.
3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.
4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.
5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.
6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access
7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.
8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.
9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.
10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.
The postpandemic path forward for GI research
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the alarming impact of COVID-19 on the biomedical research community. The Institute has taken steps to address the pandemic’s immediate challenges, such as supporting COVID-19 research within its mission and implementing policies that ease grantees’ concerns about funding and lost time. The NIDDK has also sought to balance the needs brought about by the pandemic with its responsibility to continue research on the many diseases and conditions in the NIDDK’s purview.
The NIDDK continues to support most research through unsolicited R01 awards. It also continues to support organized consortia that aim to improve our understanding and treatment of digestive diseases; research centers that provide valuable sources of collaboration among researchers investigating digestive diseases and/or nutrition and obesity; and programs that encourage transitions to different career levels.
The pandemic has shown in stark relief the devastating impact of health disparities. Because many NIDDK mission diseases place disparate burdens on minority groups and people with limited resources, the NIDDK remains committed to combating health disparities, whether pandemic related or not. The Institute recruits diverse study cohorts inclusive of those most affected. It seeks to open doors for young people from underrepresented groups through training, support, and inspiration to pursue research careers, such as through partnerships with organizations like the American Gastroenterological Association. The NIDDK is also implementing strategies to promote participant engagement, not only as study volunteers, but also in study design, recruitment, and consent. And, importantly, the Institute is supporting research to identify the causes of health disparities, including research on social determinants of health.
This year, the NIDDK embarked on the development of a 5-year Strategic Plan to develop a broad vision for accelerating research on diseases and conditions across its mission. This plan is meant to be overarching and will complement the NIDDK’s disease-specific planning efforts. The first draft of the plan is currently being developed based on the input received from a Strategic Plan Working Group (which includes several AGA members), a public Request for Information, and NIDDK’s Advisory Council. The draft will be available through the NIDDK website (niddk.nih.gov) for public comment.
By taking these actions, the NIDDK aims to continue reducing the burden of digestive diseases and improving health for all people.
Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. He has no conflicts. Dr. Rodgers made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the alarming impact of COVID-19 on the biomedical research community. The Institute has taken steps to address the pandemic’s immediate challenges, such as supporting COVID-19 research within its mission and implementing policies that ease grantees’ concerns about funding and lost time. The NIDDK has also sought to balance the needs brought about by the pandemic with its responsibility to continue research on the many diseases and conditions in the NIDDK’s purview.
The NIDDK continues to support most research through unsolicited R01 awards. It also continues to support organized consortia that aim to improve our understanding and treatment of digestive diseases; research centers that provide valuable sources of collaboration among researchers investigating digestive diseases and/or nutrition and obesity; and programs that encourage transitions to different career levels.
The pandemic has shown in stark relief the devastating impact of health disparities. Because many NIDDK mission diseases place disparate burdens on minority groups and people with limited resources, the NIDDK remains committed to combating health disparities, whether pandemic related or not. The Institute recruits diverse study cohorts inclusive of those most affected. It seeks to open doors for young people from underrepresented groups through training, support, and inspiration to pursue research careers, such as through partnerships with organizations like the American Gastroenterological Association. The NIDDK is also implementing strategies to promote participant engagement, not only as study volunteers, but also in study design, recruitment, and consent. And, importantly, the Institute is supporting research to identify the causes of health disparities, including research on social determinants of health.
This year, the NIDDK embarked on the development of a 5-year Strategic Plan to develop a broad vision for accelerating research on diseases and conditions across its mission. This plan is meant to be overarching and will complement the NIDDK’s disease-specific planning efforts. The first draft of the plan is currently being developed based on the input received from a Strategic Plan Working Group (which includes several AGA members), a public Request for Information, and NIDDK’s Advisory Council. The draft will be available through the NIDDK website (niddk.nih.gov) for public comment.
By taking these actions, the NIDDK aims to continue reducing the burden of digestive diseases and improving health for all people.
Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. He has no conflicts. Dr. Rodgers made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the alarming impact of COVID-19 on the biomedical research community. The Institute has taken steps to address the pandemic’s immediate challenges, such as supporting COVID-19 research within its mission and implementing policies that ease grantees’ concerns about funding and lost time. The NIDDK has also sought to balance the needs brought about by the pandemic with its responsibility to continue research on the many diseases and conditions in the NIDDK’s purview.
The NIDDK continues to support most research through unsolicited R01 awards. It also continues to support organized consortia that aim to improve our understanding and treatment of digestive diseases; research centers that provide valuable sources of collaboration among researchers investigating digestive diseases and/or nutrition and obesity; and programs that encourage transitions to different career levels.
The pandemic has shown in stark relief the devastating impact of health disparities. Because many NIDDK mission diseases place disparate burdens on minority groups and people with limited resources, the NIDDK remains committed to combating health disparities, whether pandemic related or not. The Institute recruits diverse study cohorts inclusive of those most affected. It seeks to open doors for young people from underrepresented groups through training, support, and inspiration to pursue research careers, such as through partnerships with organizations like the American Gastroenterological Association. The NIDDK is also implementing strategies to promote participant engagement, not only as study volunteers, but also in study design, recruitment, and consent. And, importantly, the Institute is supporting research to identify the causes of health disparities, including research on social determinants of health.
This year, the NIDDK embarked on the development of a 5-year Strategic Plan to develop a broad vision for accelerating research on diseases and conditions across its mission. This plan is meant to be overarching and will complement the NIDDK’s disease-specific planning efforts. The first draft of the plan is currently being developed based on the input received from a Strategic Plan Working Group (which includes several AGA members), a public Request for Information, and NIDDK’s Advisory Council. The draft will be available through the NIDDK website (niddk.nih.gov) for public comment.
By taking these actions, the NIDDK aims to continue reducing the burden of digestive diseases and improving health for all people.
Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. He has no conflicts. Dr. Rodgers made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
The making of the Pfizer-BioNTech COVID-19 vaccine
Days after the World Health Organization declared the COVID-19 outbreak a global pandemic, Pfizer and BioNTech announced plans to codevelop a potential mRNA-based vaccine to help prevent COVID-19. The mRNA platform was selected given its potential for high potency and capacity for rapid development. A bold decision was made to invest in R&D and manufacturing at risk.
Two candidates, BNT162b1 and BNT162b2, quickly emerged as most promising. After extensive review of preclinical and early clinical data and in consultation with regulators, we advanced BNT162b2 into a global, Phase 2/3 efficacy trial in July 2020.
Enrollment was later expanded to increase diversity, and also to include adolescents 12 and older and people with chronic, stable HIV, Hepatitis C, or Hepatitis B.
In November 2020, we announced the results of our ongoing Phase 3 study with BNT162b2 demonstrating a vaccine efficacy rate of 95% against COVID-19 beginning 28 days after dose one. This result showed our ability to leverage decades of scientific expertise to execute a rigorous Phase 3 clinical program to make a potential vaccine available as quickly and safely as possible. The emergency use authorization that followed was a big step, but our research did not stop there.
Pfizer and BioNTech continue to evaluate data from the landmark trial, which ultimately enrolled 46,331 participants. We are also conducting trials in special populations, such as pregnant women and children under 12. To date, real-world evidence has demonstrated lower COVID-19 incidence in vaccinated individuals and has not shown escape of variant viruses from BNT162b2-mediated protection. Studies are ongoing to explore the effect of a third dose on immunity and to prepare in case a variant emerges that escapes protection.
We continue to identify improvements to increase production and are on track to deliver approximately 2.5 billion doses in 2021. Next generation ready-to-use and freeze-dried formulations are in development.
This pandemic sparked an unparalleled period of innovation, investment, and partnership with lessons learned that will help us prepare for future pandemics and accelerate R&D of therapeutic candidates for other debilitating and life-threatening conditions.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use to prevent COVID-19 in individuals 12+. See conditions of use: http://cvdvaccine.com
Dr. Dolsten is the Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer. He has no other conflicts. Dr. Dolsten made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
Days after the World Health Organization declared the COVID-19 outbreak a global pandemic, Pfizer and BioNTech announced plans to codevelop a potential mRNA-based vaccine to help prevent COVID-19. The mRNA platform was selected given its potential for high potency and capacity for rapid development. A bold decision was made to invest in R&D and manufacturing at risk.
Two candidates, BNT162b1 and BNT162b2, quickly emerged as most promising. After extensive review of preclinical and early clinical data and in consultation with regulators, we advanced BNT162b2 into a global, Phase 2/3 efficacy trial in July 2020.
Enrollment was later expanded to increase diversity, and also to include adolescents 12 and older and people with chronic, stable HIV, Hepatitis C, or Hepatitis B.
In November 2020, we announced the results of our ongoing Phase 3 study with BNT162b2 demonstrating a vaccine efficacy rate of 95% against COVID-19 beginning 28 days after dose one. This result showed our ability to leverage decades of scientific expertise to execute a rigorous Phase 3 clinical program to make a potential vaccine available as quickly and safely as possible. The emergency use authorization that followed was a big step, but our research did not stop there.
Pfizer and BioNTech continue to evaluate data from the landmark trial, which ultimately enrolled 46,331 participants. We are also conducting trials in special populations, such as pregnant women and children under 12. To date, real-world evidence has demonstrated lower COVID-19 incidence in vaccinated individuals and has not shown escape of variant viruses from BNT162b2-mediated protection. Studies are ongoing to explore the effect of a third dose on immunity and to prepare in case a variant emerges that escapes protection.
We continue to identify improvements to increase production and are on track to deliver approximately 2.5 billion doses in 2021. Next generation ready-to-use and freeze-dried formulations are in development.
This pandemic sparked an unparalleled period of innovation, investment, and partnership with lessons learned that will help us prepare for future pandemics and accelerate R&D of therapeutic candidates for other debilitating and life-threatening conditions.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use to prevent COVID-19 in individuals 12+. See conditions of use: http://cvdvaccine.com
Dr. Dolsten is the Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer. He has no other conflicts. Dr. Dolsten made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
Days after the World Health Organization declared the COVID-19 outbreak a global pandemic, Pfizer and BioNTech announced plans to codevelop a potential mRNA-based vaccine to help prevent COVID-19. The mRNA platform was selected given its potential for high potency and capacity for rapid development. A bold decision was made to invest in R&D and manufacturing at risk.
Two candidates, BNT162b1 and BNT162b2, quickly emerged as most promising. After extensive review of preclinical and early clinical data and in consultation with regulators, we advanced BNT162b2 into a global, Phase 2/3 efficacy trial in July 2020.
Enrollment was later expanded to increase diversity, and also to include adolescents 12 and older and people with chronic, stable HIV, Hepatitis C, or Hepatitis B.
In November 2020, we announced the results of our ongoing Phase 3 study with BNT162b2 demonstrating a vaccine efficacy rate of 95% against COVID-19 beginning 28 days after dose one. This result showed our ability to leverage decades of scientific expertise to execute a rigorous Phase 3 clinical program to make a potential vaccine available as quickly and safely as possible. The emergency use authorization that followed was a big step, but our research did not stop there.
Pfizer and BioNTech continue to evaluate data from the landmark trial, which ultimately enrolled 46,331 participants. We are also conducting trials in special populations, such as pregnant women and children under 12. To date, real-world evidence has demonstrated lower COVID-19 incidence in vaccinated individuals and has not shown escape of variant viruses from BNT162b2-mediated protection. Studies are ongoing to explore the effect of a third dose on immunity and to prepare in case a variant emerges that escapes protection.
We continue to identify improvements to increase production and are on track to deliver approximately 2.5 billion doses in 2021. Next generation ready-to-use and freeze-dried formulations are in development.
This pandemic sparked an unparalleled period of innovation, investment, and partnership with lessons learned that will help us prepare for future pandemics and accelerate R&D of therapeutic candidates for other debilitating and life-threatening conditions.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use to prevent COVID-19 in individuals 12+. See conditions of use: http://cvdvaccine.com
Dr. Dolsten is the Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer. He has no other conflicts. Dr. Dolsten made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
Malaria study shows remarkable 70% reduction in severe disease and death
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually.
Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this parasitic infection. Most of the burden (94%) occurs in Africa, and children younger than age 5 account for 67% of the deaths.
In the Sahel region of Africa, a broad, sub-Saharan band that stretches across the continent, high malaria transmission is seasonal. Children in some countries there are treated with monthly courses of sulfadoxine-pyrimethamine and amodiaquine chemoprophylaxis during the four higher-risk months. Such seasonal malaria chemoprophylaxis (SMC) has been shown to reduce infections by up to 88% and costs an average of $3.43 per child per year.
This double-blind, randomized controlled trial enrolled young children (5-17 months old) in Burkina Faso and Mali, where SMC is the current treatment regimen. Nearly 6,000 children received either chemoprophylaxis, the RTS,S/AS01E malaria vaccine (RTS,S), or both treatments. The study, led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), was reported in the New England Journal of Medicine.
Co-lead investigator Daniel Chandramohan, MBBS, PhD, MSc, professor of public health at LSHTM, said in an interview that SMC administration is quite labor-intensive and that “we thought we can replace these four cycles of seasonal cure prevention with one seasonal vaccination like the flu vaccine ... and that there might be some additive benefit.”
Instead, the study found the combination reduces the incidence of malaria by 62% against clinical malaria infection, 70% against severe malaria, and 73% against death from malaria compared with SMC alone. “Not in our wildest dreams would I have hypothesized that this is a possibility,” Dr. Chandramohan said. He continued that this was unlikely a “freak result” because the findings are “consistent between both countries. Two, it is consistent across the years. Three, all the malaria outcomes ... are consistently showing the protective effect at the same level.”
To maintain the blinded study design, children received injections of rabies vaccine and hepatitis A vaccine instead of a placebo for RTS,S. Both were chosen to provide additional benefits by protecting children against those infections.
With so many children followed over years, accuracy in providing the correct treatment for each study arm can be difficult. Each child was given a QR code and picture identification to facilitate drug distribution each year in this study.
Miriam K. Laufer, MD, professor and associate director for malaria research at the University of Maryland, Baltimore, who was not involved in the study, said in an interview, “This is a spectacular result, you know, decreasing disease by 60%-70% using interventions that we already have.”
RTS,S is not a new vaccine; it was developed in 2001 by GlaxoSmithKline with Path’s Malaria Vaccine Initiative, then manufactured by GSK. The Gates Foundation has supported production. Dr. Chandramohan said GSK has transferred the technology to Bharat, in India, and that it will take 2-3 years to ramp up production. Until then, enough vaccine is available to supply Kenya, Malawi, and Ghana, where the pilot studies are being done.
Dr. Laufer stressed that the “group that got RTS,S did as well as the group that received SMC.” She noted that the use of SMC is limited to specific areas of the Sahel sub-region of Africa, with a brief transmission period. In other areas of Africa where malaria has a longer transmission period, SMC isn’t as effective. “RTS,S vaccine could really have an impact” there, she added.
Asked if RTS,S might be substituted for SMC to reduce the likelihood of resistance emerging, Dr. Laufer said, “Giving RTS,S vaccine is as good as using repeated treatment of malaria drugs during the malaria season. And that’s important for two reasons. One is that the advantage of a vaccine is that you’re not producing pressure of drugs that would enable drug resistance to emerge and spread. So maybe your vaccine efficacy could last longer than drug efficacy. We don’t know the answer to that.”
Hypothesizing about the unexpectedly good trial results, Dr. Laufer explained, “We know that RTS,S decreases the number of parasites that make it into the blood when a child is bitten by an infected mosquito. When drugs like sulfadoxine-pyrimethamine and amodiaquine that have moderate efficacy only have to kill off a small number of parasites, they can work better. Maybe that explains why the combination of RTS,S and SMC created such a positive outcome.”
Dr. Laufer echoed Chandramohan, saying, “Results were much more dramatic than anybody – certainly than I anticipated.” Both physicians anticipate that WHO will give full approval for this combination this fall.
Dr. Chandramohan and Dr. Laufer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually.
Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this parasitic infection. Most of the burden (94%) occurs in Africa, and children younger than age 5 account for 67% of the deaths.
In the Sahel region of Africa, a broad, sub-Saharan band that stretches across the continent, high malaria transmission is seasonal. Children in some countries there are treated with monthly courses of sulfadoxine-pyrimethamine and amodiaquine chemoprophylaxis during the four higher-risk months. Such seasonal malaria chemoprophylaxis (SMC) has been shown to reduce infections by up to 88% and costs an average of $3.43 per child per year.
This double-blind, randomized controlled trial enrolled young children (5-17 months old) in Burkina Faso and Mali, where SMC is the current treatment regimen. Nearly 6,000 children received either chemoprophylaxis, the RTS,S/AS01E malaria vaccine (RTS,S), or both treatments. The study, led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), was reported in the New England Journal of Medicine.
Co-lead investigator Daniel Chandramohan, MBBS, PhD, MSc, professor of public health at LSHTM, said in an interview that SMC administration is quite labor-intensive and that “we thought we can replace these four cycles of seasonal cure prevention with one seasonal vaccination like the flu vaccine ... and that there might be some additive benefit.”
Instead, the study found the combination reduces the incidence of malaria by 62% against clinical malaria infection, 70% against severe malaria, and 73% against death from malaria compared with SMC alone. “Not in our wildest dreams would I have hypothesized that this is a possibility,” Dr. Chandramohan said. He continued that this was unlikely a “freak result” because the findings are “consistent between both countries. Two, it is consistent across the years. Three, all the malaria outcomes ... are consistently showing the protective effect at the same level.”
To maintain the blinded study design, children received injections of rabies vaccine and hepatitis A vaccine instead of a placebo for RTS,S. Both were chosen to provide additional benefits by protecting children against those infections.
With so many children followed over years, accuracy in providing the correct treatment for each study arm can be difficult. Each child was given a QR code and picture identification to facilitate drug distribution each year in this study.
Miriam K. Laufer, MD, professor and associate director for malaria research at the University of Maryland, Baltimore, who was not involved in the study, said in an interview, “This is a spectacular result, you know, decreasing disease by 60%-70% using interventions that we already have.”
RTS,S is not a new vaccine; it was developed in 2001 by GlaxoSmithKline with Path’s Malaria Vaccine Initiative, then manufactured by GSK. The Gates Foundation has supported production. Dr. Chandramohan said GSK has transferred the technology to Bharat, in India, and that it will take 2-3 years to ramp up production. Until then, enough vaccine is available to supply Kenya, Malawi, and Ghana, where the pilot studies are being done.
Dr. Laufer stressed that the “group that got RTS,S did as well as the group that received SMC.” She noted that the use of SMC is limited to specific areas of the Sahel sub-region of Africa, with a brief transmission period. In other areas of Africa where malaria has a longer transmission period, SMC isn’t as effective. “RTS,S vaccine could really have an impact” there, she added.
Asked if RTS,S might be substituted for SMC to reduce the likelihood of resistance emerging, Dr. Laufer said, “Giving RTS,S vaccine is as good as using repeated treatment of malaria drugs during the malaria season. And that’s important for two reasons. One is that the advantage of a vaccine is that you’re not producing pressure of drugs that would enable drug resistance to emerge and spread. So maybe your vaccine efficacy could last longer than drug efficacy. We don’t know the answer to that.”
Hypothesizing about the unexpectedly good trial results, Dr. Laufer explained, “We know that RTS,S decreases the number of parasites that make it into the blood when a child is bitten by an infected mosquito. When drugs like sulfadoxine-pyrimethamine and amodiaquine that have moderate efficacy only have to kill off a small number of parasites, they can work better. Maybe that explains why the combination of RTS,S and SMC created such a positive outcome.”
Dr. Laufer echoed Chandramohan, saying, “Results were much more dramatic than anybody – certainly than I anticipated.” Both physicians anticipate that WHO will give full approval for this combination this fall.
Dr. Chandramohan and Dr. Laufer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually.
Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this parasitic infection. Most of the burden (94%) occurs in Africa, and children younger than age 5 account for 67% of the deaths.
In the Sahel region of Africa, a broad, sub-Saharan band that stretches across the continent, high malaria transmission is seasonal. Children in some countries there are treated with monthly courses of sulfadoxine-pyrimethamine and amodiaquine chemoprophylaxis during the four higher-risk months. Such seasonal malaria chemoprophylaxis (SMC) has been shown to reduce infections by up to 88% and costs an average of $3.43 per child per year.
This double-blind, randomized controlled trial enrolled young children (5-17 months old) in Burkina Faso and Mali, where SMC is the current treatment regimen. Nearly 6,000 children received either chemoprophylaxis, the RTS,S/AS01E malaria vaccine (RTS,S), or both treatments. The study, led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), was reported in the New England Journal of Medicine.
Co-lead investigator Daniel Chandramohan, MBBS, PhD, MSc, professor of public health at LSHTM, said in an interview that SMC administration is quite labor-intensive and that “we thought we can replace these four cycles of seasonal cure prevention with one seasonal vaccination like the flu vaccine ... and that there might be some additive benefit.”
Instead, the study found the combination reduces the incidence of malaria by 62% against clinical malaria infection, 70% against severe malaria, and 73% against death from malaria compared with SMC alone. “Not in our wildest dreams would I have hypothesized that this is a possibility,” Dr. Chandramohan said. He continued that this was unlikely a “freak result” because the findings are “consistent between both countries. Two, it is consistent across the years. Three, all the malaria outcomes ... are consistently showing the protective effect at the same level.”
To maintain the blinded study design, children received injections of rabies vaccine and hepatitis A vaccine instead of a placebo for RTS,S. Both were chosen to provide additional benefits by protecting children against those infections.
With so many children followed over years, accuracy in providing the correct treatment for each study arm can be difficult. Each child was given a QR code and picture identification to facilitate drug distribution each year in this study.
Miriam K. Laufer, MD, professor and associate director for malaria research at the University of Maryland, Baltimore, who was not involved in the study, said in an interview, “This is a spectacular result, you know, decreasing disease by 60%-70% using interventions that we already have.”
RTS,S is not a new vaccine; it was developed in 2001 by GlaxoSmithKline with Path’s Malaria Vaccine Initiative, then manufactured by GSK. The Gates Foundation has supported production. Dr. Chandramohan said GSK has transferred the technology to Bharat, in India, and that it will take 2-3 years to ramp up production. Until then, enough vaccine is available to supply Kenya, Malawi, and Ghana, where the pilot studies are being done.
Dr. Laufer stressed that the “group that got RTS,S did as well as the group that received SMC.” She noted that the use of SMC is limited to specific areas of the Sahel sub-region of Africa, with a brief transmission period. In other areas of Africa where malaria has a longer transmission period, SMC isn’t as effective. “RTS,S vaccine could really have an impact” there, she added.
Asked if RTS,S might be substituted for SMC to reduce the likelihood of resistance emerging, Dr. Laufer said, “Giving RTS,S vaccine is as good as using repeated treatment of malaria drugs during the malaria season. And that’s important for two reasons. One is that the advantage of a vaccine is that you’re not producing pressure of drugs that would enable drug resistance to emerge and spread. So maybe your vaccine efficacy could last longer than drug efficacy. We don’t know the answer to that.”
Hypothesizing about the unexpectedly good trial results, Dr. Laufer explained, “We know that RTS,S decreases the number of parasites that make it into the blood when a child is bitten by an infected mosquito. When drugs like sulfadoxine-pyrimethamine and amodiaquine that have moderate efficacy only have to kill off a small number of parasites, they can work better. Maybe that explains why the combination of RTS,S and SMC created such a positive outcome.”
Dr. Laufer echoed Chandramohan, saying, “Results were much more dramatic than anybody – certainly than I anticipated.” Both physicians anticipate that WHO will give full approval for this combination this fall.
Dr. Chandramohan and Dr. Laufer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
What’s your diagnosis?
Choledocopyloric fistula secondary to peptic ulcer disease.
This patient has a known history of prepyloric peptic ulcer disease and related gastric outlet obstruction requiring two previous dilations. Upon endoscopic examination, we observed high-grade obstruction at the pylorus similar to previous examinations. During the initial positioning of the balloon for dilation, we inadvertently cannulated the fistula located in the pyloric channel using the guidewire (arrow in Figure D) and were able to characterize its anatomy upon contrast administration (Figure C). However, after repositioning the guidewire into the duodenal lumen beyond pyloric stricture, the balloon was inflated to a maximal diameter of 15 mm under fluoroscopic guidance. Discounting other common causes, our patient presented with an infrequent occurrence of choledocopyloric fistula secondary to peptic ulcer disease.
The most common cause of choledocoenteric fistula is bile duct inflammation due to gallstone formation, while other minor causes include neoplasms, ulcers, and inflammation of neighboring organs.1 Additionally, in recent years, fistula formation is a relatively rare complication of peptic ulcer disease due to the increased effectiveness of ulcer drugs.2 Similar to this patient's condition, cholangitis, jaundice, or anomaly of biological liver examinations are rarely observed. Consequently, diagnosis is mainly incidental with pneumobilia being the most helpful marker present in 50% of cases.3 Because cholangitis and biliary sequelae remain rare, choledocoenteric fistulas do not warrant prophylactic surgical treatment. As a result, treatment is generally focused on the underlying ulcer disease.
The quiz authors disclose no conflicts.
References
1. Stagnitti F et al. G Chir. 2000 Mar;21(3):110-7.
2. Wu MB et al. Ann Surg Treat Res. 2015 Nov;89(5):240-6.
3. Dewulf E et al. J Chir (Paris). 1987 Jan;124(1):19-23.
Previously published in Gastroenterology (2019 Oct;157[4]:936-7).
Choledocopyloric fistula secondary to peptic ulcer disease.
This patient has a known history of prepyloric peptic ulcer disease and related gastric outlet obstruction requiring two previous dilations. Upon endoscopic examination, we observed high-grade obstruction at the pylorus similar to previous examinations. During the initial positioning of the balloon for dilation, we inadvertently cannulated the fistula located in the pyloric channel using the guidewire (arrow in Figure D) and were able to characterize its anatomy upon contrast administration (Figure C). However, after repositioning the guidewire into the duodenal lumen beyond pyloric stricture, the balloon was inflated to a maximal diameter of 15 mm under fluoroscopic guidance. Discounting other common causes, our patient presented with an infrequent occurrence of choledocopyloric fistula secondary to peptic ulcer disease.
The most common cause of choledocoenteric fistula is bile duct inflammation due to gallstone formation, while other minor causes include neoplasms, ulcers, and inflammation of neighboring organs.1 Additionally, in recent years, fistula formation is a relatively rare complication of peptic ulcer disease due to the increased effectiveness of ulcer drugs.2 Similar to this patient's condition, cholangitis, jaundice, or anomaly of biological liver examinations are rarely observed. Consequently, diagnosis is mainly incidental with pneumobilia being the most helpful marker present in 50% of cases.3 Because cholangitis and biliary sequelae remain rare, choledocoenteric fistulas do not warrant prophylactic surgical treatment. As a result, treatment is generally focused on the underlying ulcer disease.
The quiz authors disclose no conflicts.
References
1. Stagnitti F et al. G Chir. 2000 Mar;21(3):110-7.
2. Wu MB et al. Ann Surg Treat Res. 2015 Nov;89(5):240-6.
3. Dewulf E et al. J Chir (Paris). 1987 Jan;124(1):19-23.
Previously published in Gastroenterology (2019 Oct;157[4]:936-7).
Choledocopyloric fistula secondary to peptic ulcer disease.
This patient has a known history of prepyloric peptic ulcer disease and related gastric outlet obstruction requiring two previous dilations. Upon endoscopic examination, we observed high-grade obstruction at the pylorus similar to previous examinations. During the initial positioning of the balloon for dilation, we inadvertently cannulated the fistula located in the pyloric channel using the guidewire (arrow in Figure D) and were able to characterize its anatomy upon contrast administration (Figure C). However, after repositioning the guidewire into the duodenal lumen beyond pyloric stricture, the balloon was inflated to a maximal diameter of 15 mm under fluoroscopic guidance. Discounting other common causes, our patient presented with an infrequent occurrence of choledocopyloric fistula secondary to peptic ulcer disease.
The most common cause of choledocoenteric fistula is bile duct inflammation due to gallstone formation, while other minor causes include neoplasms, ulcers, and inflammation of neighboring organs.1 Additionally, in recent years, fistula formation is a relatively rare complication of peptic ulcer disease due to the increased effectiveness of ulcer drugs.2 Similar to this patient's condition, cholangitis, jaundice, or anomaly of biological liver examinations are rarely observed. Consequently, diagnosis is mainly incidental with pneumobilia being the most helpful marker present in 50% of cases.3 Because cholangitis and biliary sequelae remain rare, choledocoenteric fistulas do not warrant prophylactic surgical treatment. As a result, treatment is generally focused on the underlying ulcer disease.
The quiz authors disclose no conflicts.
References
1. Stagnitti F et al. G Chir. 2000 Mar;21(3):110-7.
2. Wu MB et al. Ann Surg Treat Res. 2015 Nov;89(5):240-6.
3. Dewulf E et al. J Chir (Paris). 1987 Jan;124(1):19-23.
Previously published in Gastroenterology (2019 Oct;157[4]:936-7).
What’s the diagnosis?
Emerging data point to underlying autoimmunity in ME/CFS
Emerging evidence suggests that autoimmunity plays a role in postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and that targeting autoantibodies could be a promising treatment approach.
The same may also apply to many cases of “long COVID,” in which many of the symptoms overlap with those of ME/CFS, Carmen Scheibenbogen, MD, professor of clinical immunology and director of the Institute for Medical Immunology, Charité University Medicine, Berlin, said during the annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.
Several groups, including Dr. Scheibenbogen’s, have reported finding autoantibodies against neurotransmitter receptor antigens in people with ME/CFS. And, in a paper published in the Journal of Clinical Medicine the day that Dr. Scheibenbogen spoke at the meeting, her team reported significant correlations between autoantibodies to vasoregulative G-protein–coupled receptors and symptom severity, autonomic dysfunction, and disability among 116 patients with infection-triggered ME/CFS who were diagnosed using the symptom-based 2003 Canadian consensus criteria.
People with ME/CFS are also more likely to have genetic risk factors associated with autoimmunity and personal and/or family histories of autoimmune conditions. And, clinical trials have demonstrated early success with various immunomodulatory treatments in subsets of people with ME/CFS, including endoxan, rituximab, and immunoadsorption.
“We have evidence that ME/CFS is an autoantibody-mediated disease, and we have evidence that autoantibody targeting is effective in this disease. So far ... we have few and underfinanced clinical studies, but the good news is we have promising emerging treatment options,” Dr. Scheibenbogen said.
Asked to comment, ME/CFS expert Anthony L. Komaroff, MD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said: “There is already strong evidence that there are autoantibodies in ME/CFS. Dr. Scheibenbogen’s work is the latest and employs the latest technology. ... I would bet that autoantibodies to neural targets are likely to cause some of the symptoms of ME/CFS and some of the symptoms of long COVID.”
However, he cautioned, “that has not been proven, and even if it were proven you would have to demonstrate that treatments based on that theory worked.”
Dr. Komaroff said he views autoimmunity as a likely component of the ME/CFS spectrum, but not the only one. “My current view of this illness is that there’s a final common pathway in the brain that leads to the symptoms of the illness. But that final common pathway can be triggered by a variety of different things, one of which could be autoantibodies while another could be infection or inflammation in the brain.”
Emerging evidence points to autoimmunity
Dr. Scheibenbogen summarized the work published in this area over the past few years by her group and others.
In a comparison of ME/CFS patients with 201 healthy controls, significant associations were seen with two specific autoimmunity-related risk alleles only in the ME/CFS patients who reported acute onset of disease with an infection but not in those with ME/CFS without infection-triggered onset or the controls. Both genes play roles in regulating B- and T-cell activation.
Another recent study found associations with ME/CFS and major histocompatibility complex class II molecules, a typical feature of autoimmune diseases, in a comparison between 426 adult Norwegian ME/CFS patients who were diagnosed with the Canadian consensus criteria and 4,511 healthy, ethnically matched controls.
In a 2020 paper, Dr. Scheibenbogen and pharmacologist Klaus Wirth presented a “unifying hypothesis” of ME/CFS pathophysiology based on the finding of elevations in autoantibodies against beta2-adrenergic receptors and muscarinic acetylcholine receptors in some individuals with the condition. Since both of those receptors are important vasodilators, their functional disturbance would be expected to cause vasoconstriction and hypoxemia, which would explain many of the symptoms of ME/CFS. This mechanism would align with other findings of muscular and cerebral hypoperfusion that correlate with fatigue, particularly post exertion, as well as metabolic changes that are in line with the concepts of hypoxemia and ischemia.
Further evidence for vascular dysfunction in ME/CFS came from her group’s study finding evidence of peripheral endothelial dysfunction that was associated with symptom severity in 35 adult patients. “Vasoconstriction, hypovolemia, and release of vasoactive and algesic mediators is probably a key pathomechanism of the disease,” Dr. Scheibenbogen said.
Treatments: Will targeting autoantibodies work?
In the second part of her talk, Dr. Scheibenbogen summarized clinical trials of the following treatment approaches that involve targeting autoantibodies as a way to alleviate ME/CFS symptoms:
Rituximab: Work on infusions of the B-cell depleting agent has been conducted by Norwegian researchers beginning in 2011 with a small randomized trial and an open-label, phase 2 study in 2015, both showing clinical responses in ME/CFS. However, a subsequent phase 3, randomized clinical trial of 151 patients, again diagnosed using the Canadian criteria, was negative.
There are several possible explanations for this, Dr. Scheibenbogen noted. For one, the maintenance dose had to be reduced because of a lack of financial support. “This was probably critical. The lower dose was insufficient to adequately deplete B cells.” Also, there may have been a strong placebo response in the control group since they were being given better care than they normally would receive during the trial. “I think probably nobody will again do a rituximab trial. This was very disappointing for all of us. But, we still have other opportunities to follow this path,” she said.
Dr. Komaroff agreed. “I don’t think the failure of one drug that hits malignant B cells is proof against the autoimmune hypothesis per se. I think the evidence is that rituximab doesn’t work, but that doesn’t invalidate the autoimmunity hypothesis.”
Cyclophosphamide: The same Norwegian group also showed positive findings in an open-label, phase 2 trial of the immune-modifying drug cyclophosphamide in 22 of 40 patients. Interestingly, HLA risk alleles were much more common in responders than nonresponders, Dr. Scheibenbogen noted.
Immunoadsorption: This technique, similar to dialysis, involves separating out the blood plasma by centrifugation and removing IgG autoantibodies by a binding column, then returning the plasma back to the patient. It is used, primarily in Europe, to treat severe autoimmune diseases including dilative cardiomyopathy and refractory systemic lupus erythematosus (SLE).
Dr. Scheibenbogen’s group has conducted two studies of immunoadsorption in ME/CFS. In one, a 5-day procedure led to rapid symptom improvement in 7 of 10 patients, with sustained improvement in 3 patients after 2 years. Autoantibodies decreased rapidly in 9 of the 10 patients. In a follow-up study of five of the responders 2 years later, retreatment with a modified immunoadsorption protocol led to rapid and sustained improvement in four. Further study has been on hold because of the pandemic.
Next-gen IgG-targeting therapies: Another approach that could offer promise for ME/CFS involves therapies that block the Fc receptors of IgG. Several are in phase 1-3 trials for autoimmune conditions. One candidate drug, the Fc fragment efgartigimod, is currently in phase 3 trials for several conditions, including generalized myasthenia gravis, primary immune thrombocytopenia, and chronic inflammatory demyelinating polyneuropathy. Phase 3 trials are planned for the monoclonal antibody rozanolixizumab in those same conditions.
Newer-generation monoclonal antibodies targeting CD19 or CD20 that show benefit in various autoimmune conditions are another possibility for ME/CFS. These include ocrelizumab (Ocrevus), approved in the United States for treating relapsing and progressive multiple sclerosis and in trials for SLE; obinutuzumab (Gazyva), approved for treating lymphoma and also in development for SLE; and ublituximab, in phase 3 trials for multiple sclerosis.
“Most of them are more effective than rituximab,” Dr. Scheibenbogen noted, adding that “currently the data look quite promising. They are effective in different autoimmune diseases and they are quite well tolerated. There’s great hope now with COVID-19 that we can convince some companies to do such trials in ME/CFS as well.”
Dr. Scheibenbogen’s institution, the Charité Fatigue Center, has a patent for beta2-adrenergic receptor antibodies for diagnosing ME/CFS under her name together with Celltrend. Dr. Komaroff has received personal fees from Serimmune.
Emerging evidence suggests that autoimmunity plays a role in postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and that targeting autoantibodies could be a promising treatment approach.
The same may also apply to many cases of “long COVID,” in which many of the symptoms overlap with those of ME/CFS, Carmen Scheibenbogen, MD, professor of clinical immunology and director of the Institute for Medical Immunology, Charité University Medicine, Berlin, said during the annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.
Several groups, including Dr. Scheibenbogen’s, have reported finding autoantibodies against neurotransmitter receptor antigens in people with ME/CFS. And, in a paper published in the Journal of Clinical Medicine the day that Dr. Scheibenbogen spoke at the meeting, her team reported significant correlations between autoantibodies to vasoregulative G-protein–coupled receptors and symptom severity, autonomic dysfunction, and disability among 116 patients with infection-triggered ME/CFS who were diagnosed using the symptom-based 2003 Canadian consensus criteria.
People with ME/CFS are also more likely to have genetic risk factors associated with autoimmunity and personal and/or family histories of autoimmune conditions. And, clinical trials have demonstrated early success with various immunomodulatory treatments in subsets of people with ME/CFS, including endoxan, rituximab, and immunoadsorption.
“We have evidence that ME/CFS is an autoantibody-mediated disease, and we have evidence that autoantibody targeting is effective in this disease. So far ... we have few and underfinanced clinical studies, but the good news is we have promising emerging treatment options,” Dr. Scheibenbogen said.
Asked to comment, ME/CFS expert Anthony L. Komaroff, MD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said: “There is already strong evidence that there are autoantibodies in ME/CFS. Dr. Scheibenbogen’s work is the latest and employs the latest technology. ... I would bet that autoantibodies to neural targets are likely to cause some of the symptoms of ME/CFS and some of the symptoms of long COVID.”
However, he cautioned, “that has not been proven, and even if it were proven you would have to demonstrate that treatments based on that theory worked.”
Dr. Komaroff said he views autoimmunity as a likely component of the ME/CFS spectrum, but not the only one. “My current view of this illness is that there’s a final common pathway in the brain that leads to the symptoms of the illness. But that final common pathway can be triggered by a variety of different things, one of which could be autoantibodies while another could be infection or inflammation in the brain.”
Emerging evidence points to autoimmunity
Dr. Scheibenbogen summarized the work published in this area over the past few years by her group and others.
In a comparison of ME/CFS patients with 201 healthy controls, significant associations were seen with two specific autoimmunity-related risk alleles only in the ME/CFS patients who reported acute onset of disease with an infection but not in those with ME/CFS without infection-triggered onset or the controls. Both genes play roles in regulating B- and T-cell activation.
Another recent study found associations with ME/CFS and major histocompatibility complex class II molecules, a typical feature of autoimmune diseases, in a comparison between 426 adult Norwegian ME/CFS patients who were diagnosed with the Canadian consensus criteria and 4,511 healthy, ethnically matched controls.
In a 2020 paper, Dr. Scheibenbogen and pharmacologist Klaus Wirth presented a “unifying hypothesis” of ME/CFS pathophysiology based on the finding of elevations in autoantibodies against beta2-adrenergic receptors and muscarinic acetylcholine receptors in some individuals with the condition. Since both of those receptors are important vasodilators, their functional disturbance would be expected to cause vasoconstriction and hypoxemia, which would explain many of the symptoms of ME/CFS. This mechanism would align with other findings of muscular and cerebral hypoperfusion that correlate with fatigue, particularly post exertion, as well as metabolic changes that are in line with the concepts of hypoxemia and ischemia.
Further evidence for vascular dysfunction in ME/CFS came from her group’s study finding evidence of peripheral endothelial dysfunction that was associated with symptom severity in 35 adult patients. “Vasoconstriction, hypovolemia, and release of vasoactive and algesic mediators is probably a key pathomechanism of the disease,” Dr. Scheibenbogen said.
Treatments: Will targeting autoantibodies work?
In the second part of her talk, Dr. Scheibenbogen summarized clinical trials of the following treatment approaches that involve targeting autoantibodies as a way to alleviate ME/CFS symptoms:
Rituximab: Work on infusions of the B-cell depleting agent has been conducted by Norwegian researchers beginning in 2011 with a small randomized trial and an open-label, phase 2 study in 2015, both showing clinical responses in ME/CFS. However, a subsequent phase 3, randomized clinical trial of 151 patients, again diagnosed using the Canadian criteria, was negative.
There are several possible explanations for this, Dr. Scheibenbogen noted. For one, the maintenance dose had to be reduced because of a lack of financial support. “This was probably critical. The lower dose was insufficient to adequately deplete B cells.” Also, there may have been a strong placebo response in the control group since they were being given better care than they normally would receive during the trial. “I think probably nobody will again do a rituximab trial. This was very disappointing for all of us. But, we still have other opportunities to follow this path,” she said.
Dr. Komaroff agreed. “I don’t think the failure of one drug that hits malignant B cells is proof against the autoimmune hypothesis per se. I think the evidence is that rituximab doesn’t work, but that doesn’t invalidate the autoimmunity hypothesis.”
Cyclophosphamide: The same Norwegian group also showed positive findings in an open-label, phase 2 trial of the immune-modifying drug cyclophosphamide in 22 of 40 patients. Interestingly, HLA risk alleles were much more common in responders than nonresponders, Dr. Scheibenbogen noted.
Immunoadsorption: This technique, similar to dialysis, involves separating out the blood plasma by centrifugation and removing IgG autoantibodies by a binding column, then returning the plasma back to the patient. It is used, primarily in Europe, to treat severe autoimmune diseases including dilative cardiomyopathy and refractory systemic lupus erythematosus (SLE).
Dr. Scheibenbogen’s group has conducted two studies of immunoadsorption in ME/CFS. In one, a 5-day procedure led to rapid symptom improvement in 7 of 10 patients, with sustained improvement in 3 patients after 2 years. Autoantibodies decreased rapidly in 9 of the 10 patients. In a follow-up study of five of the responders 2 years later, retreatment with a modified immunoadsorption protocol led to rapid and sustained improvement in four. Further study has been on hold because of the pandemic.
Next-gen IgG-targeting therapies: Another approach that could offer promise for ME/CFS involves therapies that block the Fc receptors of IgG. Several are in phase 1-3 trials for autoimmune conditions. One candidate drug, the Fc fragment efgartigimod, is currently in phase 3 trials for several conditions, including generalized myasthenia gravis, primary immune thrombocytopenia, and chronic inflammatory demyelinating polyneuropathy. Phase 3 trials are planned for the monoclonal antibody rozanolixizumab in those same conditions.
Newer-generation monoclonal antibodies targeting CD19 or CD20 that show benefit in various autoimmune conditions are another possibility for ME/CFS. These include ocrelizumab (Ocrevus), approved in the United States for treating relapsing and progressive multiple sclerosis and in trials for SLE; obinutuzumab (Gazyva), approved for treating lymphoma and also in development for SLE; and ublituximab, in phase 3 trials for multiple sclerosis.
“Most of them are more effective than rituximab,” Dr. Scheibenbogen noted, adding that “currently the data look quite promising. They are effective in different autoimmune diseases and they are quite well tolerated. There’s great hope now with COVID-19 that we can convince some companies to do such trials in ME/CFS as well.”
Dr. Scheibenbogen’s institution, the Charité Fatigue Center, has a patent for beta2-adrenergic receptor antibodies for diagnosing ME/CFS under her name together with Celltrend. Dr. Komaroff has received personal fees from Serimmune.
Emerging evidence suggests that autoimmunity plays a role in postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and that targeting autoantibodies could be a promising treatment approach.
The same may also apply to many cases of “long COVID,” in which many of the symptoms overlap with those of ME/CFS, Carmen Scheibenbogen, MD, professor of clinical immunology and director of the Institute for Medical Immunology, Charité University Medicine, Berlin, said during the annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.
Several groups, including Dr. Scheibenbogen’s, have reported finding autoantibodies against neurotransmitter receptor antigens in people with ME/CFS. And, in a paper published in the Journal of Clinical Medicine the day that Dr. Scheibenbogen spoke at the meeting, her team reported significant correlations between autoantibodies to vasoregulative G-protein–coupled receptors and symptom severity, autonomic dysfunction, and disability among 116 patients with infection-triggered ME/CFS who were diagnosed using the symptom-based 2003 Canadian consensus criteria.
People with ME/CFS are also more likely to have genetic risk factors associated with autoimmunity and personal and/or family histories of autoimmune conditions. And, clinical trials have demonstrated early success with various immunomodulatory treatments in subsets of people with ME/CFS, including endoxan, rituximab, and immunoadsorption.
“We have evidence that ME/CFS is an autoantibody-mediated disease, and we have evidence that autoantibody targeting is effective in this disease. So far ... we have few and underfinanced clinical studies, but the good news is we have promising emerging treatment options,” Dr. Scheibenbogen said.
Asked to comment, ME/CFS expert Anthony L. Komaroff, MD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said: “There is already strong evidence that there are autoantibodies in ME/CFS. Dr. Scheibenbogen’s work is the latest and employs the latest technology. ... I would bet that autoantibodies to neural targets are likely to cause some of the symptoms of ME/CFS and some of the symptoms of long COVID.”
However, he cautioned, “that has not been proven, and even if it were proven you would have to demonstrate that treatments based on that theory worked.”
Dr. Komaroff said he views autoimmunity as a likely component of the ME/CFS spectrum, but not the only one. “My current view of this illness is that there’s a final common pathway in the brain that leads to the symptoms of the illness. But that final common pathway can be triggered by a variety of different things, one of which could be autoantibodies while another could be infection or inflammation in the brain.”
Emerging evidence points to autoimmunity
Dr. Scheibenbogen summarized the work published in this area over the past few years by her group and others.
In a comparison of ME/CFS patients with 201 healthy controls, significant associations were seen with two specific autoimmunity-related risk alleles only in the ME/CFS patients who reported acute onset of disease with an infection but not in those with ME/CFS without infection-triggered onset or the controls. Both genes play roles in regulating B- and T-cell activation.
Another recent study found associations with ME/CFS and major histocompatibility complex class II molecules, a typical feature of autoimmune diseases, in a comparison between 426 adult Norwegian ME/CFS patients who were diagnosed with the Canadian consensus criteria and 4,511 healthy, ethnically matched controls.
In a 2020 paper, Dr. Scheibenbogen and pharmacologist Klaus Wirth presented a “unifying hypothesis” of ME/CFS pathophysiology based on the finding of elevations in autoantibodies against beta2-adrenergic receptors and muscarinic acetylcholine receptors in some individuals with the condition. Since both of those receptors are important vasodilators, their functional disturbance would be expected to cause vasoconstriction and hypoxemia, which would explain many of the symptoms of ME/CFS. This mechanism would align with other findings of muscular and cerebral hypoperfusion that correlate with fatigue, particularly post exertion, as well as metabolic changes that are in line with the concepts of hypoxemia and ischemia.
Further evidence for vascular dysfunction in ME/CFS came from her group’s study finding evidence of peripheral endothelial dysfunction that was associated with symptom severity in 35 adult patients. “Vasoconstriction, hypovolemia, and release of vasoactive and algesic mediators is probably a key pathomechanism of the disease,” Dr. Scheibenbogen said.
Treatments: Will targeting autoantibodies work?
In the second part of her talk, Dr. Scheibenbogen summarized clinical trials of the following treatment approaches that involve targeting autoantibodies as a way to alleviate ME/CFS symptoms:
Rituximab: Work on infusions of the B-cell depleting agent has been conducted by Norwegian researchers beginning in 2011 with a small randomized trial and an open-label, phase 2 study in 2015, both showing clinical responses in ME/CFS. However, a subsequent phase 3, randomized clinical trial of 151 patients, again diagnosed using the Canadian criteria, was negative.
There are several possible explanations for this, Dr. Scheibenbogen noted. For one, the maintenance dose had to be reduced because of a lack of financial support. “This was probably critical. The lower dose was insufficient to adequately deplete B cells.” Also, there may have been a strong placebo response in the control group since they were being given better care than they normally would receive during the trial. “I think probably nobody will again do a rituximab trial. This was very disappointing for all of us. But, we still have other opportunities to follow this path,” she said.
Dr. Komaroff agreed. “I don’t think the failure of one drug that hits malignant B cells is proof against the autoimmune hypothesis per se. I think the evidence is that rituximab doesn’t work, but that doesn’t invalidate the autoimmunity hypothesis.”
Cyclophosphamide: The same Norwegian group also showed positive findings in an open-label, phase 2 trial of the immune-modifying drug cyclophosphamide in 22 of 40 patients. Interestingly, HLA risk alleles were much more common in responders than nonresponders, Dr. Scheibenbogen noted.
Immunoadsorption: This technique, similar to dialysis, involves separating out the blood plasma by centrifugation and removing IgG autoantibodies by a binding column, then returning the plasma back to the patient. It is used, primarily in Europe, to treat severe autoimmune diseases including dilative cardiomyopathy and refractory systemic lupus erythematosus (SLE).
Dr. Scheibenbogen’s group has conducted two studies of immunoadsorption in ME/CFS. In one, a 5-day procedure led to rapid symptom improvement in 7 of 10 patients, with sustained improvement in 3 patients after 2 years. Autoantibodies decreased rapidly in 9 of the 10 patients. In a follow-up study of five of the responders 2 years later, retreatment with a modified immunoadsorption protocol led to rapid and sustained improvement in four. Further study has been on hold because of the pandemic.
Next-gen IgG-targeting therapies: Another approach that could offer promise for ME/CFS involves therapies that block the Fc receptors of IgG. Several are in phase 1-3 trials for autoimmune conditions. One candidate drug, the Fc fragment efgartigimod, is currently in phase 3 trials for several conditions, including generalized myasthenia gravis, primary immune thrombocytopenia, and chronic inflammatory demyelinating polyneuropathy. Phase 3 trials are planned for the monoclonal antibody rozanolixizumab in those same conditions.
Newer-generation monoclonal antibodies targeting CD19 or CD20 that show benefit in various autoimmune conditions are another possibility for ME/CFS. These include ocrelizumab (Ocrevus), approved in the United States for treating relapsing and progressive multiple sclerosis and in trials for SLE; obinutuzumab (Gazyva), approved for treating lymphoma and also in development for SLE; and ublituximab, in phase 3 trials for multiple sclerosis.
“Most of them are more effective than rituximab,” Dr. Scheibenbogen noted, adding that “currently the data look quite promising. They are effective in different autoimmune diseases and they are quite well tolerated. There’s great hope now with COVID-19 that we can convince some companies to do such trials in ME/CFS as well.”
Dr. Scheibenbogen’s institution, the Charité Fatigue Center, has a patent for beta2-adrenergic receptor antibodies for diagnosing ME/CFS under her name together with Celltrend. Dr. Komaroff has received personal fees from Serimmune.
FROM IACFS/ME 2021
From past to future
This month, the current Editor-in-Chief and his Editorial Board will conclude our 5-year term. Megan Adams MD, JD, MSc, from the University of Michigan School of Medicine will assume my position. She has a stellar academic, research, and teaching record and is one of the best writers I know. She and her Board of Editors will carry on the tradition of GIHN.
The idea of an official newspaper of the AGA came from AGA staff in 2006. The goals of the newspaper were twofold: to communicate the latest news and information to practitioners to help them stay at the forefront of patient care and to develop another revenue stream for our society. The newspaper was launched in January 2007 with Charles Lightdale MD, AGAF, as the first editor and Colin W. Howden MD, AGAF, as the second (each with 5-year terms). While they wrote occasional editorials, I began writing 300-word essays for each issue. I have tried diligently to maintain a balanced viewpoint for all my editorials, although this has been difficult in the recent past and current national environment.
The paper evolved from a simple print publication to a multimedia communications vehicle that includes online-only content, videos, supplements, quizzes, and more. Last year, we published our first “Data Trends,” a supplement containing 10 or so brief articles written by content experts, covering current topics of high interest. As the paper evolved, we broadened our target audience to include research scientists, international practitioners and others interested in digestive diseases.
As I did last month, I would like to thank the AGA and Frontline Medical Communications staff for their dedication and constant work to bring you this newspaper.
Finally, I would like to pay tribute to Tadataka “Tachi” Yamada, who died this last month at the age of 76 years. He was one of the premier advocates for global health. His contributions to our field thru research, philanthropy, and leadership were enormous. We will miss him greatly.
John I Allen, MD, MBA, AGAF
Editor in Chief
This month, the current Editor-in-Chief and his Editorial Board will conclude our 5-year term. Megan Adams MD, JD, MSc, from the University of Michigan School of Medicine will assume my position. She has a stellar academic, research, and teaching record and is one of the best writers I know. She and her Board of Editors will carry on the tradition of GIHN.
The idea of an official newspaper of the AGA came from AGA staff in 2006. The goals of the newspaper were twofold: to communicate the latest news and information to practitioners to help them stay at the forefront of patient care and to develop another revenue stream for our society. The newspaper was launched in January 2007 with Charles Lightdale MD, AGAF, as the first editor and Colin W. Howden MD, AGAF, as the second (each with 5-year terms). While they wrote occasional editorials, I began writing 300-word essays for each issue. I have tried diligently to maintain a balanced viewpoint for all my editorials, although this has been difficult in the recent past and current national environment.
The paper evolved from a simple print publication to a multimedia communications vehicle that includes online-only content, videos, supplements, quizzes, and more. Last year, we published our first “Data Trends,” a supplement containing 10 or so brief articles written by content experts, covering current topics of high interest. As the paper evolved, we broadened our target audience to include research scientists, international practitioners and others interested in digestive diseases.
As I did last month, I would like to thank the AGA and Frontline Medical Communications staff for their dedication and constant work to bring you this newspaper.
Finally, I would like to pay tribute to Tadataka “Tachi” Yamada, who died this last month at the age of 76 years. He was one of the premier advocates for global health. His contributions to our field thru research, philanthropy, and leadership were enormous. We will miss him greatly.
John I Allen, MD, MBA, AGAF
Editor in Chief
This month, the current Editor-in-Chief and his Editorial Board will conclude our 5-year term. Megan Adams MD, JD, MSc, from the University of Michigan School of Medicine will assume my position. She has a stellar academic, research, and teaching record and is one of the best writers I know. She and her Board of Editors will carry on the tradition of GIHN.
The idea of an official newspaper of the AGA came from AGA staff in 2006. The goals of the newspaper were twofold: to communicate the latest news and information to practitioners to help them stay at the forefront of patient care and to develop another revenue stream for our society. The newspaper was launched in January 2007 with Charles Lightdale MD, AGAF, as the first editor and Colin W. Howden MD, AGAF, as the second (each with 5-year terms). While they wrote occasional editorials, I began writing 300-word essays for each issue. I have tried diligently to maintain a balanced viewpoint for all my editorials, although this has been difficult in the recent past and current national environment.
The paper evolved from a simple print publication to a multimedia communications vehicle that includes online-only content, videos, supplements, quizzes, and more. Last year, we published our first “Data Trends,” a supplement containing 10 or so brief articles written by content experts, covering current topics of high interest. As the paper evolved, we broadened our target audience to include research scientists, international practitioners and others interested in digestive diseases.
As I did last month, I would like to thank the AGA and Frontline Medical Communications staff for their dedication and constant work to bring you this newspaper.
Finally, I would like to pay tribute to Tadataka “Tachi” Yamada, who died this last month at the age of 76 years. He was one of the premier advocates for global health. His contributions to our field thru research, philanthropy, and leadership were enormous. We will miss him greatly.
John I Allen, MD, MBA, AGAF
Editor in Chief
The other epidemic: Violence against health care workers
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
The secret I’ll take to my grave: Doc reveals
An internist will never forget the dark secret his patient revealed during a routine visit – or the grim aftermath.
The patient, who had a progressive, incurable neurological condition, confided that he planned to kill himself. The patient intended to conceal the true manner and make the death look natural.
“[He planned to do it] very carefully at home so no one would know,” said the internist, who remains anonymous. “[He shared] the methods he would use.”
Perhaps more shocking than the patient’s confession was the physician’s response.
“He did not require my help to do what he planned, and I did not try to stop him,” said the internist. “I reported his death as ‘natural causes’ and never told anyone.”
An ob.gyn., for instance, wrote about struggling with whether to tell a father that his newborn baby was not his genetic child. The newborn had a blood type that made it impossible for the father to be biologically related to the infant, the anonymous doctor wrote.
“I told the wife who then informed me she had a lover,” the ob.gyn. said. “I never told the husband.”
It’s uncertain whether carrying the burden of such hidden knowledge affected the physicians involved in these cases. However, in general, secrets can weigh heavily on the minds of those who keep them and can contribute to stress, said Malia Mason, PhD, a psychologist and dean of research at Columbia Business School in New York. Holding onto secrets can cause depression and anxiety, research shows. The more often people think about the secret, the greater the impact, according to a recent study coauthored by Dr. Mason.
“Keeping a secret diminishes well-being,” Dr. Mason said. “It makes people feel socially distant. It lowers relationship satisfaction, and it leads people to feel inauthentic. The reason that secrets do this is because people think about them all the time. The more you think about it, the more you see these consequences.”
Feelings that stem from a secret depend on the content. The more immoral a secret is thought to be, the more people feel ashamed, according to a 2021 analysis of thousands of secrets, reported by Michael L. Slepian, PhD, and Alex Koch, PhD. However, secrets more related to a person’s profession are often internalized differently, the study found. The more a secret fell higher on the profession/goal-oriented dimension, the more people felt they had insight into the secret, according to the analysis. For example, having clear thinking about the secret and/or knowing how to handle it.
“The more shame participants felt from their secret, the more they indicated the secret hurt their well-being,” Dr. Slepian and Dr. Koch wrote in the study. “The more insight participants felt they had into their secret, the less they indicated the secret hurt their well-being.”
Suspicious deaths exposed after investigations
The internist’s account of keeping his patient’s suicide a secret raises many questions, such as how the patient masked his manner of death. The internist did not share any more details about the incident.
Suicides are among the most challenging manners of deaths to certify, according to James Gill, MD, a pathologist and president of the National Association of Medical Examiners. Death investigators must demonstrate intent, meaning the individuals caused the injury to intentionally harm themselves. Fewer than half of people who die by suicide leave a note, Dr. Gill said, so investigators can’t rely on the absence or the presence of a note in making their determination.
A decedent who had cancer or a severe neurological disorder presents further challenges, said Dr. Gill, who serves as chief medical examiner for the state of Connecticut.
“These [deaths] may not be unexpected and may not be reported to the medical examiner/coroner,” Dr. Gill said. “If there is no suspicion and the treating doctor is willing to sign the death certificate, the death will not come under the jurisdiction of the medical examiner.”
Dr. Gill recalled a death his colleague once investigated that appeared to be natural but emerged as something else after a deeper look.
A woman with metastatic breast cancer was about to be discharged from a hospital into hospice the next morning. The night before, she had a “going away” party with friends who came to visit her in the hospital. Shortly after the friends left, the woman was found dead. Because of her condition, she could have died at any time, Dr. Gill said, but she also had a history of depression and hospital staff were suspicious. The death was reported to the medical examiner’s office.
Toxicology testing found markedly elevated concentrations of phenytoin and pentobarbital, neither of which were prescribed during her hospital stay. Dr. Gill said it turned out that the woman and her friends worked at a veterinarian’s office, and the medication they used to euthanize dogs was a combination of phenytoin and pentobarbital.
“The death was certified as a homicide because of the direct actions of another, but a reasonable argument could be made for suicide,” Dr. Gill said.
In a similar case reported in the journal Science & Justice, a 64-year-old cardiologist was found lifeless by his wife after he collapsed near the stairs of his home. Next to his body was a bottle of whiskey and two cups, one that appeared to be used for the alcohol and one with a yellowish liquid smelling of honey. The wife reported that her husband always drank whiskey with honey before bed. The death was initially classified as natural, but after vehement protest by the family, a forensic autopsy was performed.
Prior to the autopsy, death investigators learned the decedent, who was a well-known and successful practitioner in his community, had Parkinson’s disease. At times, he could not sign his prescriptions because of the increasing tremor in his hands, according to the case study. Investigators learned the patient’s mother had also suffered from Parkinson’s, and that her son had witnessed her decline.
The autopsy revealed only nonspecific lesions such as acute stasis of the viscera, moderate pulmonary and cerebral edema, and moderate generalized atheromatosis. Histological examinations did not yield any unusual findings.
An analysis of the beverage containers detected pentobarbital in the yellowish syrup residue of the second cup. Testing of the doctor’s peripheral blood revealed the presence of a metabolite of pentobarbital, ethanol, and traces of phenobarbital. In addition, a urine analysis showed the presence of venlafaxine, an antidepressant, as well as the benzophenone of lorazepam, a sedating benzodiazepine, and metoclopramide, an antiemetic.
Lead author C. Brandt-Casadevall, MD, and colleagues wrote that the levels were clearly compatible with a scenario of a pentobarbital overdose with a lethal outcome.
“... It is obvious that the victim attempted to hide his suicide from his family circle,” Dr. Brandt-Casadevall and colleagues wrote. “Thus, we obtained no evidence indicating that he might have spoken at any point of putting an end to his life. There was no written note. The victim did not wait to be alone at home. Instead, he committed his act in a routine situation: his wife was watching television late at night and he was upstairs, presumably going to sleep. Thus, he had one to two hours at his disposal, and he ingested a very fast-acting drug which would make any attempt at reanimation impossible, even after a brief period of time. This may have induced the physician in charge to believe that the cause of death was cardiac origin, a likely hypothesis given the age of the victim.”
What to do when a terminally ill patient talks suicide
When a terminally ill patient expresses the desire to end his or her life, it’s important to understand that desire is often a result of existential suffering, a sense of hopelessness, and lack of social support, said Lynn A. Jansen, PhD, a bioethicist at the University of Arizona in Tucson.
“The duty of beneficence requires that physicians attempt to provide the support and care that is needed,” said Dr. Jansen. “Here, interdisciplinary teamwork is important and should be utilized. Physicians should refer patients to professionals, such as social workers, pastoral care, psychologists, etc., who are better able to address these issues.”
The rate of desire for a hastened death among terminally ill patients ranges from 17% to 45%, depending on the population studied and how the desire is evaluated, according to an analysis in the Primary Care Companion to the Journal of Clinical Psychiatry. In one study, 14% of about 130 palliative care patients with cancer had a strong desire to quicken the dying process.
In addition, patients with neurologic disorders have a significantly higher suicide rate than that of those without neurologic disorders, a recent JAMA study found. About 1 in 150 patients diagnosed with a neurological disorder dies by suicide, the analysis determined.
A tricky point to remember is that a desire by a terminally ill patient to hasten his or her death by suicide should not be taken by itself to indicate depression, Dr. Jansen noted.
“In principle, such patients can make an autonomous decision to end their lives,” she said. “However, the expression of such a desire is very often associated with depression and forms of suffering that can be effectively addressed by the health care team.”
Physicians can also explore other avenues with the patient such as palliative care or making sure adequate pain relief is available, added Robert Klitzman, MD, professor of psychiatry and academic director of the master of science in bioethics program at Columbia University, New York.
“If they are saying it’s because they are distressed, ethically, a doctor can and should find ways to decrease their distress,” he said.
Of course, those who practice in the U.S. jurisdictions that have physician-assisted-dying laws have different legal and ethical elements to consider. Physicians in these areas have no ethical duty to participate in the process, Dr. Jansen said, but they have a duty to refer patients who express a desire to pursue physician aid-in-dying to another provider who can assist them.
Physician aid-in-dying laws vary somewhat so it’s important that physicians in these areas be aware of their specific statute, Dr. Klitzman said. California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, Washington, and the District of Columbia have these laws.
“In these states, if a terminally ill patient says they don’t want to live anymore, a physician would first decide if this is a result of depression or if it’s a request for physician aid-in-dying,” he said. “Even then, in most cases, the patient would be evaluated by not one, but two different health professionals at two different points. We want to see if it is a consistent decision that the person has made that they want physician aid-in-dying, and not just that they’ve had a bad day or a setback in their treatment.”
In the case of the internist who told no one of his patient’s suicide plan, Dr. Klitzman said he would have dug deeper into the patient’s mindset.
“Not knowing anything about the patient or the doctor, I would have responded differently,” he said. “I think a physician should address why a patient feels that way. They may feel their pain is unbearable, and we potentially offer more pain relief. Maybe the patient shows evidence of having depression, which may be treatable [with medication]. The patient would then feel better and be able to spend quality time with family and loved ones, make sure their affairs are in order, and have a chance to say goodbye.”
A version of this article first appeared on Medscape.com.
An internist will never forget the dark secret his patient revealed during a routine visit – or the grim aftermath.
The patient, who had a progressive, incurable neurological condition, confided that he planned to kill himself. The patient intended to conceal the true manner and make the death look natural.
“[He planned to do it] very carefully at home so no one would know,” said the internist, who remains anonymous. “[He shared] the methods he would use.”
Perhaps more shocking than the patient’s confession was the physician’s response.
“He did not require my help to do what he planned, and I did not try to stop him,” said the internist. “I reported his death as ‘natural causes’ and never told anyone.”
An ob.gyn., for instance, wrote about struggling with whether to tell a father that his newborn baby was not his genetic child. The newborn had a blood type that made it impossible for the father to be biologically related to the infant, the anonymous doctor wrote.
“I told the wife who then informed me she had a lover,” the ob.gyn. said. “I never told the husband.”
It’s uncertain whether carrying the burden of such hidden knowledge affected the physicians involved in these cases. However, in general, secrets can weigh heavily on the minds of those who keep them and can contribute to stress, said Malia Mason, PhD, a psychologist and dean of research at Columbia Business School in New York. Holding onto secrets can cause depression and anxiety, research shows. The more often people think about the secret, the greater the impact, according to a recent study coauthored by Dr. Mason.
“Keeping a secret diminishes well-being,” Dr. Mason said. “It makes people feel socially distant. It lowers relationship satisfaction, and it leads people to feel inauthentic. The reason that secrets do this is because people think about them all the time. The more you think about it, the more you see these consequences.”
Feelings that stem from a secret depend on the content. The more immoral a secret is thought to be, the more people feel ashamed, according to a 2021 analysis of thousands of secrets, reported by Michael L. Slepian, PhD, and Alex Koch, PhD. However, secrets more related to a person’s profession are often internalized differently, the study found. The more a secret fell higher on the profession/goal-oriented dimension, the more people felt they had insight into the secret, according to the analysis. For example, having clear thinking about the secret and/or knowing how to handle it.
“The more shame participants felt from their secret, the more they indicated the secret hurt their well-being,” Dr. Slepian and Dr. Koch wrote in the study. “The more insight participants felt they had into their secret, the less they indicated the secret hurt their well-being.”
Suspicious deaths exposed after investigations
The internist’s account of keeping his patient’s suicide a secret raises many questions, such as how the patient masked his manner of death. The internist did not share any more details about the incident.
Suicides are among the most challenging manners of deaths to certify, according to James Gill, MD, a pathologist and president of the National Association of Medical Examiners. Death investigators must demonstrate intent, meaning the individuals caused the injury to intentionally harm themselves. Fewer than half of people who die by suicide leave a note, Dr. Gill said, so investigators can’t rely on the absence or the presence of a note in making their determination.
A decedent who had cancer or a severe neurological disorder presents further challenges, said Dr. Gill, who serves as chief medical examiner for the state of Connecticut.
“These [deaths] may not be unexpected and may not be reported to the medical examiner/coroner,” Dr. Gill said. “If there is no suspicion and the treating doctor is willing to sign the death certificate, the death will not come under the jurisdiction of the medical examiner.”
Dr. Gill recalled a death his colleague once investigated that appeared to be natural but emerged as something else after a deeper look.
A woman with metastatic breast cancer was about to be discharged from a hospital into hospice the next morning. The night before, she had a “going away” party with friends who came to visit her in the hospital. Shortly after the friends left, the woman was found dead. Because of her condition, she could have died at any time, Dr. Gill said, but she also had a history of depression and hospital staff were suspicious. The death was reported to the medical examiner’s office.
Toxicology testing found markedly elevated concentrations of phenytoin and pentobarbital, neither of which were prescribed during her hospital stay. Dr. Gill said it turned out that the woman and her friends worked at a veterinarian’s office, and the medication they used to euthanize dogs was a combination of phenytoin and pentobarbital.
“The death was certified as a homicide because of the direct actions of another, but a reasonable argument could be made for suicide,” Dr. Gill said.
In a similar case reported in the journal Science & Justice, a 64-year-old cardiologist was found lifeless by his wife after he collapsed near the stairs of his home. Next to his body was a bottle of whiskey and two cups, one that appeared to be used for the alcohol and one with a yellowish liquid smelling of honey. The wife reported that her husband always drank whiskey with honey before bed. The death was initially classified as natural, but after vehement protest by the family, a forensic autopsy was performed.
Prior to the autopsy, death investigators learned the decedent, who was a well-known and successful practitioner in his community, had Parkinson’s disease. At times, he could not sign his prescriptions because of the increasing tremor in his hands, according to the case study. Investigators learned the patient’s mother had also suffered from Parkinson’s, and that her son had witnessed her decline.
The autopsy revealed only nonspecific lesions such as acute stasis of the viscera, moderate pulmonary and cerebral edema, and moderate generalized atheromatosis. Histological examinations did not yield any unusual findings.
An analysis of the beverage containers detected pentobarbital in the yellowish syrup residue of the second cup. Testing of the doctor’s peripheral blood revealed the presence of a metabolite of pentobarbital, ethanol, and traces of phenobarbital. In addition, a urine analysis showed the presence of venlafaxine, an antidepressant, as well as the benzophenone of lorazepam, a sedating benzodiazepine, and metoclopramide, an antiemetic.
Lead author C. Brandt-Casadevall, MD, and colleagues wrote that the levels were clearly compatible with a scenario of a pentobarbital overdose with a lethal outcome.
“... It is obvious that the victim attempted to hide his suicide from his family circle,” Dr. Brandt-Casadevall and colleagues wrote. “Thus, we obtained no evidence indicating that he might have spoken at any point of putting an end to his life. There was no written note. The victim did not wait to be alone at home. Instead, he committed his act in a routine situation: his wife was watching television late at night and he was upstairs, presumably going to sleep. Thus, he had one to two hours at his disposal, and he ingested a very fast-acting drug which would make any attempt at reanimation impossible, even after a brief period of time. This may have induced the physician in charge to believe that the cause of death was cardiac origin, a likely hypothesis given the age of the victim.”
What to do when a terminally ill patient talks suicide
When a terminally ill patient expresses the desire to end his or her life, it’s important to understand that desire is often a result of existential suffering, a sense of hopelessness, and lack of social support, said Lynn A. Jansen, PhD, a bioethicist at the University of Arizona in Tucson.
“The duty of beneficence requires that physicians attempt to provide the support and care that is needed,” said Dr. Jansen. “Here, interdisciplinary teamwork is important and should be utilized. Physicians should refer patients to professionals, such as social workers, pastoral care, psychologists, etc., who are better able to address these issues.”
The rate of desire for a hastened death among terminally ill patients ranges from 17% to 45%, depending on the population studied and how the desire is evaluated, according to an analysis in the Primary Care Companion to the Journal of Clinical Psychiatry. In one study, 14% of about 130 palliative care patients with cancer had a strong desire to quicken the dying process.
In addition, patients with neurologic disorders have a significantly higher suicide rate than that of those without neurologic disorders, a recent JAMA study found. About 1 in 150 patients diagnosed with a neurological disorder dies by suicide, the analysis determined.
A tricky point to remember is that a desire by a terminally ill patient to hasten his or her death by suicide should not be taken by itself to indicate depression, Dr. Jansen noted.
“In principle, such patients can make an autonomous decision to end their lives,” she said. “However, the expression of such a desire is very often associated with depression and forms of suffering that can be effectively addressed by the health care team.”
Physicians can also explore other avenues with the patient such as palliative care or making sure adequate pain relief is available, added Robert Klitzman, MD, professor of psychiatry and academic director of the master of science in bioethics program at Columbia University, New York.
“If they are saying it’s because they are distressed, ethically, a doctor can and should find ways to decrease their distress,” he said.
Of course, those who practice in the U.S. jurisdictions that have physician-assisted-dying laws have different legal and ethical elements to consider. Physicians in these areas have no ethical duty to participate in the process, Dr. Jansen said, but they have a duty to refer patients who express a desire to pursue physician aid-in-dying to another provider who can assist them.
Physician aid-in-dying laws vary somewhat so it’s important that physicians in these areas be aware of their specific statute, Dr. Klitzman said. California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, Washington, and the District of Columbia have these laws.
“In these states, if a terminally ill patient says they don’t want to live anymore, a physician would first decide if this is a result of depression or if it’s a request for physician aid-in-dying,” he said. “Even then, in most cases, the patient would be evaluated by not one, but two different health professionals at two different points. We want to see if it is a consistent decision that the person has made that they want physician aid-in-dying, and not just that they’ve had a bad day or a setback in their treatment.”
In the case of the internist who told no one of his patient’s suicide plan, Dr. Klitzman said he would have dug deeper into the patient’s mindset.
“Not knowing anything about the patient or the doctor, I would have responded differently,” he said. “I think a physician should address why a patient feels that way. They may feel their pain is unbearable, and we potentially offer more pain relief. Maybe the patient shows evidence of having depression, which may be treatable [with medication]. The patient would then feel better and be able to spend quality time with family and loved ones, make sure their affairs are in order, and have a chance to say goodbye.”
A version of this article first appeared on Medscape.com.
An internist will never forget the dark secret his patient revealed during a routine visit – or the grim aftermath.
The patient, who had a progressive, incurable neurological condition, confided that he planned to kill himself. The patient intended to conceal the true manner and make the death look natural.
“[He planned to do it] very carefully at home so no one would know,” said the internist, who remains anonymous. “[He shared] the methods he would use.”
Perhaps more shocking than the patient’s confession was the physician’s response.
“He did not require my help to do what he planned, and I did not try to stop him,” said the internist. “I reported his death as ‘natural causes’ and never told anyone.”
An ob.gyn., for instance, wrote about struggling with whether to tell a father that his newborn baby was not his genetic child. The newborn had a blood type that made it impossible for the father to be biologically related to the infant, the anonymous doctor wrote.
“I told the wife who then informed me she had a lover,” the ob.gyn. said. “I never told the husband.”
It’s uncertain whether carrying the burden of such hidden knowledge affected the physicians involved in these cases. However, in general, secrets can weigh heavily on the minds of those who keep them and can contribute to stress, said Malia Mason, PhD, a psychologist and dean of research at Columbia Business School in New York. Holding onto secrets can cause depression and anxiety, research shows. The more often people think about the secret, the greater the impact, according to a recent study coauthored by Dr. Mason.
“Keeping a secret diminishes well-being,” Dr. Mason said. “It makes people feel socially distant. It lowers relationship satisfaction, and it leads people to feel inauthentic. The reason that secrets do this is because people think about them all the time. The more you think about it, the more you see these consequences.”
Feelings that stem from a secret depend on the content. The more immoral a secret is thought to be, the more people feel ashamed, according to a 2021 analysis of thousands of secrets, reported by Michael L. Slepian, PhD, and Alex Koch, PhD. However, secrets more related to a person’s profession are often internalized differently, the study found. The more a secret fell higher on the profession/goal-oriented dimension, the more people felt they had insight into the secret, according to the analysis. For example, having clear thinking about the secret and/or knowing how to handle it.
“The more shame participants felt from their secret, the more they indicated the secret hurt their well-being,” Dr. Slepian and Dr. Koch wrote in the study. “The more insight participants felt they had into their secret, the less they indicated the secret hurt their well-being.”
Suspicious deaths exposed after investigations
The internist’s account of keeping his patient’s suicide a secret raises many questions, such as how the patient masked his manner of death. The internist did not share any more details about the incident.
Suicides are among the most challenging manners of deaths to certify, according to James Gill, MD, a pathologist and president of the National Association of Medical Examiners. Death investigators must demonstrate intent, meaning the individuals caused the injury to intentionally harm themselves. Fewer than half of people who die by suicide leave a note, Dr. Gill said, so investigators can’t rely on the absence or the presence of a note in making their determination.
A decedent who had cancer or a severe neurological disorder presents further challenges, said Dr. Gill, who serves as chief medical examiner for the state of Connecticut.
“These [deaths] may not be unexpected and may not be reported to the medical examiner/coroner,” Dr. Gill said. “If there is no suspicion and the treating doctor is willing to sign the death certificate, the death will not come under the jurisdiction of the medical examiner.”
Dr. Gill recalled a death his colleague once investigated that appeared to be natural but emerged as something else after a deeper look.
A woman with metastatic breast cancer was about to be discharged from a hospital into hospice the next morning. The night before, she had a “going away” party with friends who came to visit her in the hospital. Shortly after the friends left, the woman was found dead. Because of her condition, she could have died at any time, Dr. Gill said, but she also had a history of depression and hospital staff were suspicious. The death was reported to the medical examiner’s office.
Toxicology testing found markedly elevated concentrations of phenytoin and pentobarbital, neither of which were prescribed during her hospital stay. Dr. Gill said it turned out that the woman and her friends worked at a veterinarian’s office, and the medication they used to euthanize dogs was a combination of phenytoin and pentobarbital.
“The death was certified as a homicide because of the direct actions of another, but a reasonable argument could be made for suicide,” Dr. Gill said.
In a similar case reported in the journal Science & Justice, a 64-year-old cardiologist was found lifeless by his wife after he collapsed near the stairs of his home. Next to his body was a bottle of whiskey and two cups, one that appeared to be used for the alcohol and one with a yellowish liquid smelling of honey. The wife reported that her husband always drank whiskey with honey before bed. The death was initially classified as natural, but after vehement protest by the family, a forensic autopsy was performed.
Prior to the autopsy, death investigators learned the decedent, who was a well-known and successful practitioner in his community, had Parkinson’s disease. At times, he could not sign his prescriptions because of the increasing tremor in his hands, according to the case study. Investigators learned the patient’s mother had also suffered from Parkinson’s, and that her son had witnessed her decline.
The autopsy revealed only nonspecific lesions such as acute stasis of the viscera, moderate pulmonary and cerebral edema, and moderate generalized atheromatosis. Histological examinations did not yield any unusual findings.
An analysis of the beverage containers detected pentobarbital in the yellowish syrup residue of the second cup. Testing of the doctor’s peripheral blood revealed the presence of a metabolite of pentobarbital, ethanol, and traces of phenobarbital. In addition, a urine analysis showed the presence of venlafaxine, an antidepressant, as well as the benzophenone of lorazepam, a sedating benzodiazepine, and metoclopramide, an antiemetic.
Lead author C. Brandt-Casadevall, MD, and colleagues wrote that the levels were clearly compatible with a scenario of a pentobarbital overdose with a lethal outcome.
“... It is obvious that the victim attempted to hide his suicide from his family circle,” Dr. Brandt-Casadevall and colleagues wrote. “Thus, we obtained no evidence indicating that he might have spoken at any point of putting an end to his life. There was no written note. The victim did not wait to be alone at home. Instead, he committed his act in a routine situation: his wife was watching television late at night and he was upstairs, presumably going to sleep. Thus, he had one to two hours at his disposal, and he ingested a very fast-acting drug which would make any attempt at reanimation impossible, even after a brief period of time. This may have induced the physician in charge to believe that the cause of death was cardiac origin, a likely hypothesis given the age of the victim.”
What to do when a terminally ill patient talks suicide
When a terminally ill patient expresses the desire to end his or her life, it’s important to understand that desire is often a result of existential suffering, a sense of hopelessness, and lack of social support, said Lynn A. Jansen, PhD, a bioethicist at the University of Arizona in Tucson.
“The duty of beneficence requires that physicians attempt to provide the support and care that is needed,” said Dr. Jansen. “Here, interdisciplinary teamwork is important and should be utilized. Physicians should refer patients to professionals, such as social workers, pastoral care, psychologists, etc., who are better able to address these issues.”
The rate of desire for a hastened death among terminally ill patients ranges from 17% to 45%, depending on the population studied and how the desire is evaluated, according to an analysis in the Primary Care Companion to the Journal of Clinical Psychiatry. In one study, 14% of about 130 palliative care patients with cancer had a strong desire to quicken the dying process.
In addition, patients with neurologic disorders have a significantly higher suicide rate than that of those without neurologic disorders, a recent JAMA study found. About 1 in 150 patients diagnosed with a neurological disorder dies by suicide, the analysis determined.
A tricky point to remember is that a desire by a terminally ill patient to hasten his or her death by suicide should not be taken by itself to indicate depression, Dr. Jansen noted.
“In principle, such patients can make an autonomous decision to end their lives,” she said. “However, the expression of such a desire is very often associated with depression and forms of suffering that can be effectively addressed by the health care team.”
Physicians can also explore other avenues with the patient such as palliative care or making sure adequate pain relief is available, added Robert Klitzman, MD, professor of psychiatry and academic director of the master of science in bioethics program at Columbia University, New York.
“If they are saying it’s because they are distressed, ethically, a doctor can and should find ways to decrease their distress,” he said.
Of course, those who practice in the U.S. jurisdictions that have physician-assisted-dying laws have different legal and ethical elements to consider. Physicians in these areas have no ethical duty to participate in the process, Dr. Jansen said, but they have a duty to refer patients who express a desire to pursue physician aid-in-dying to another provider who can assist them.
Physician aid-in-dying laws vary somewhat so it’s important that physicians in these areas be aware of their specific statute, Dr. Klitzman said. California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, Washington, and the District of Columbia have these laws.
“In these states, if a terminally ill patient says they don’t want to live anymore, a physician would first decide if this is a result of depression or if it’s a request for physician aid-in-dying,” he said. “Even then, in most cases, the patient would be evaluated by not one, but two different health professionals at two different points. We want to see if it is a consistent decision that the person has made that they want physician aid-in-dying, and not just that they’ve had a bad day or a setback in their treatment.”
In the case of the internist who told no one of his patient’s suicide plan, Dr. Klitzman said he would have dug deeper into the patient’s mindset.
“Not knowing anything about the patient or the doctor, I would have responded differently,” he said. “I think a physician should address why a patient feels that way. They may feel their pain is unbearable, and we potentially offer more pain relief. Maybe the patient shows evidence of having depression, which may be treatable [with medication]. The patient would then feel better and be able to spend quality time with family and loved ones, make sure their affairs are in order, and have a chance to say goodbye.”
A version of this article first appeared on Medscape.com.